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Paxil Five-Year Litigation History

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Message Evelyn Pringle
It would be difficult to find a better career than employment as a GlaxoSmithKline attorney, especially if job security is a top priority. Not a year goes by when the company is not doling out millions of dollars to defend against charges involving corporate misconduct of one kind or another.

A limited review of the company's involvement in the legal system over just the last five years reveals a clear pattern of habitual corruption. However, although Glaxo has paid billions of dollars in accumulated fines, penalties and awards to plaintiffs in civil cases, not one company official has been arrested and charged with a crime.

Glaxo's latest escapade was revealed on October 5, 2006, when Bloomberg News reported that Glaxo conducted a recall of Paxil CR, a selective serotonin reuptake inhibitor antidepressant, last month because some of the pills may lack an active ingredient, but that the company did not warn patients who may be taking the useless pills.

Doctors told Bloomberg that patients who either abruptly stop taking Paxil or get inactive pills, can face the risk of suicidal thoughts, shooting pains and flu like symptoms.

The Paxil CR pills are the highest dose sold, and can cause severe withdrawal symptoms, according to Dr Stephen Ellen, a psychiatrist from the University of Massachusetts Medical School in Worcester. "If it is true that patients might have gotten dummy pills without knowing it, it is outrageous," he said.

According to Glaxo, the FDA knew about the problem and approved the limited recall plan, but FDA spokeswoman, Susan Cruzan, told Bloomberg that she did not know the details of the September Paxil CR recall.

This incident is even more outrageous because back on March 4, 2005, the government cited Glaxo for the exact same wrongdoing when the FDA and the Department of Justice initiated the seizure of Paxil CR tablets after Glaxo failed to meet the standards laid out by the FDA to ensure product safety, strength, quality and purity.

Among the violations noted then by the FDA, was the finding that the tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect.

The seizures followed warrants issued by the U.S. District Courts for the District of Puerto Rico and the Eastern District of Tennessee and were executed by the U.S. Marshals Service at Glaxo's Cidra, Puerto Rico manufacturing facility, its Knoxville, Tennessee distribution facility, and a Puerto Rico distribution center.

The FDA said that Glaxo had voluntarily recalled some of the affected lots of Paxil CR but had failed to recall all of the affected lots and that failure resulted in the seizures by federal authorities.

"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John Taylor, FDA Associate Commissioner for Regulatory Affairs in a statement released by the agency at the time.

"Once we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner," Mr Taylor stated.

"American consumers," he said, "deserve the best health care products on the market today, and companies that are not adhering to these standards cannot assure FDA and American consumers of the quality of their products."

A month and a half later, on April 28, 2005, the FDA announced that Glaxo had signed a consent decree to correct the manufacturing deficiencies at its Cidra, Puerto Rico facility.

However, the consent decree required Glaxo to post a penal bond of $650,000,000 contingent upon either successfully reconditioning the drugs seized in March 2005, or destroying them and paying the costs to the government.

To resolve the matter, Glaxo supposedly recalled all of the lots of Paxil CR made before November 2004, and agreed to an independent quality review of the manufacturing.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
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